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Blog

Paradigm – ahead of schedule

Scott Power

  • PAR have released an update on the recruitment number for the Phase 2b osteoarthritis/bone marrow lesions trial.
  • Recruitment tracking ahead of expectations.
  • Plenty of upcoming news flow with clinical trial results and real-world read outs from the special access scheme.

Company profile

Paradigm (PAR) is an Australian biopharmaceutical company focused on repurposing the drug pentosane polysulfate sodium (PPS) primarily in the orthopaedic treatment of osteoarthritis (OA) and bone marrow edema lesions (BMEL). By repurposing existing drugs, PAR is able to utilise a shortened development pathway through the various drug approval agencies.

What is PPS?

PPS is a semi-synthetic compound made from European Beech trees and has been in use over the last 60 years in Europe for the treatment and prevention of blood clots. PPS is generally characterised as anti-inflammatory, anti-histamine, anti-clotting, prevents premature cell death (necrosis), and also prevents cartilage degeneration.

PAR's primary use for the drug is the treatment of BMEL through slowing the breakdown of cartilage in the joint as well as significantly reducing joint pain and function without the use of opioid or non-steroidal anti-inflammatory drugs (NSAIDs). Successful preclinical studies and treatments via the TGA's special access scheme (SAS) have helped to drive recent confidence in the efficacy of the drug in these indications.

Major shareholders: Paul Rennie (21.1%), other board and management (7.0%), MJGD Nominees (6.8%, Irwin Biotech (6.2%).

Cash & burn: A$2.2m cash (plus A$5.75m from placement) and operating cash outflow of A$0.3m for the September 2017 quarter which included A$1.8m R&D tax rebate.

Morgans Corporate Limited was Joint Lead manager to the recent placement.

Updates

PAR reported 23% (23/100) patients have already been signed up in its Phase 2b OA/BMEL trial which commenced recruitment late October. The numbers are well ahead of initial company expectations and have received significant inbound interest.

Expectations of results from the trial have now moved up to Q4CY18 from Q1CY19.

In conjunction with the OA/BMEL trial, PAR are also running a Phase 2a viral arthritis resulting from Ross River Fever trial. Recruitment is >60% complete with results readout on track for mid-2018. PAR anticipate a further influx of participants over the coming months as mosquito numbers rise into summer.

Upcoming milestones

Recruitment numbers in Phase 2b OA/BMEL trial.

Ongoing release of SAS patient outcomes. PAR plans to release these outcomes every 20-25 patients completed (n ~ 100).

Phase 2a viral arthritis trial results 2QCY18.

Potential partnership agreements with major pharmaceutical companies in treatments for BMEL with OA.

Phase 2b OA/BMEL clinical trial results (n = 100) – Q4CY18.

Watch the video:

Paul Rennie Chief Executive Officer at Paradigm Biopharma provides an update on the progress of the company as at 2 November 2017.

More information

Morgans clients can access our detailed research on all companies we cover in the Healthcare sector. If you are interested in finding out more, please contact your nearest Morgans office.

Disclaimer(s): Morgans Corporate Limited was a Joint Lead Manager to the recent placement and received fees in this regard.

Analyst owns shares.

The information contained in this report is provided to you by Morgans Financial Limited as general advice only, and is made without consideration of an individual's relevant personal circumstances. Morgans Financial Limited ABN 49 010 669 726, its related bodies corporate, directors and officers, employees, authorised representatives and agents (“Morgans”) do not accept any liability for any loss or damage arising from or in connection with any action taken or not taken on the basis of information contained in this report, or for any errors or omissions contained within. It is recommended that any persons who wish to act upon this report consult with their Morgans investment adviser before doing so.